Study to Assess the Non-inferiority of Pamorelin® 11,25mg SC Injected Versus Pamorelin® 11,25mg IM Injected in Patients Suffering From Advanced Prostate Cancer (PAMOJECT)

Prostate Cancer Clinical Trial

Official title:

Phase II Multi-Centric, Randomised, Open-label, Parallel-Group Study to Assess the Non-inferiority of Pamorelin® 11,25mg SC Injected Versus Pamorelin® 11,25mg IM Injected in Patients Suffering From Advanced Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00444639
• Other study ID #: I-48-52014-142
• Secondary ID: 2005-005058-31
• Status: Terminated
• Phase: Phase 2
• Start date: February 2007
• Est. completion date: June 2008

Study information

• Verified date: November 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The active ingredient of Pamorelin® 11,25 mg is Triptorelin. Triptorelin is a substitute for a natural hormone produced in the body called Gonadotrophin-releasing hormone (GnRH). GnRH is a hormone secreted by hypothalamus (a gland located in brain) and controls the production of sex hormones (eg testosterone in men) in other organs in the body. The growth of prostate cancer cells, one of the most common cancers in men, is induced by the hormone testosterone. Hormonotherapy is one of treatments available to treat this type of disease by controlling the testosterone serum level. Pamorelin® 11,25 mg is normally injected in the muscle but this type of injection is not suitable for every patient. Therefore the primary purpose of this study is to assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin® 11,25 mg administered via standard intramuscular (IM) injection based on the percentage of patients presenting a testosterone level ≤ 50 ng/dl at week 24.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: June 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy

• Life expectancy of more than 9 months

• Documented testosterone levels of = 125 ng/dl measured by any laboratory or on site within the previous 6 months

Exclusion Criteria:

• Has a history of hypersensitivity to the Investigational Medicinal Product or drugs with a similar chemical structure

• Has previously received a GnRH analogue, estrogens or a steroidal anti -androgen within the last year preceding the study

• Concomitant anti-coagulation treatment

• Patient who underwent an orchidectomy or who is scheduled to receive an orchidectomy during the course of this study

• Patient with known spinal medullar compression

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Triptorelin (Decapeptyl®)
Two injections of 11.25mg given every 12 weeks

Locations

Country	Name	City	State
Netherlands	AMC Amsterdam	Amsterdam
Netherlands	Vrije Universiteit Medisch Centrum	Amsterdam
Netherlands	Alysis Zorggroep Loc. Rijnstate	Arnhem
Netherlands	Maasziekenhuis Pantein	Boxmeer
Netherlands	Deventer Ziekenhuis	Deventer
Netherlands	Ziekenhuis Gelderse Vallei	Ede
Netherlands	St. Anna Ziekenhuis Geldrop	Geldrop
Netherlands	Groen Hart Ziekenhuis	Gouda
Netherlands	Ziekenhuis Hilversum	Hilversum
Netherlands	Westfries Gasthuis Hoorn	Hoorn
Netherlands	Diaconessenhuis Leiden	Leiden
Netherlands	Erasmus MC Rotterdam	Rotterdam
Netherlands	Antonius Ziekenhuis	Sneek
Netherlands	UMC Utrecht	Utrecht
Netherlands	Albert Schweitzer Ziekenhuis	Zwijndrecht

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients achieving a plasma testosterone level = 50 ng/dl (1,7 nmol/l).		Week 24
Secondary	Patient acceptability of the injection; the pain experienced during injection, scored by means of a Visual Analogue Scale (VAS).		Measured at baseline and 12 weeks
Secondary	Care giver acceptability of the administration of the injection by means of a Visual Analogue Scale (VAS).		Measured at baseline and 12 weeks
Secondary	Percentage of patients achieving a plasma testosterone level = 50 ng/dl (1,7 nmol/l).		Measured at week 12